Robert L Johnston1, Aaron Y Lee2, Miranda Buckle3, Richard Antcliff4, Clare Bailey3, Martin McKibbin5, Usha Chakravarthy6, Adnan Tufail7. 1. Department of Ophthalmology, Gloucestershire Hospitals National Health Services Foundation Trust, Cheltenham Hospital, Cheltenham, United Kingdom. 2. Department of Ophthalmology, University of Washington, Seattle, Washington; Moorfields Eye Hospital, City Road, London, United Kingdom. Electronic address: leeay@uw.edu. 3. Retina Service, Bristol Eye Hospital, Bristol, United Kingdom. 4. Department of Ophthalmology, Royal United Hospitals Bath National Health Services Foundation Trust, Bath, United Kingdom. 5. Eye Clinic, St. James's University Hospital, Leeds, United Kingdom. 6. Centre for Vascular and Vision Sciences, Queen's University, Belfast, United Kingdom. 7. Moorfields Eye Hospital, City Road, London, United Kingdom.
Abstract
PURPOSE: To study the incidence of blindness and sight impairment in treatment-naive patients receiving ranibizumab (Lucentis) for neovascular age-related macular degeneration (nAMD) in the United Kingdom (UK) National Health Service. DESIGN: Multicenter nAMD database study. PARTICIPANTS: A total of 11 135 patients who collectively received 92 976 treatment episodes to 12 951 eyes. METHODS: Data were extracted from 14 UK centers using the same electronic medical record system (EMR). The EMR-mandated collection of a data set (defined before first data entry) including: age, Early Treatment Diabetic Retinopathy Study visual acuity letter score (VA) for both eyes at all visits, and injection episodes. Participating centers used overwhelmingly a pro re nata re-treatment posology at intended monthly follow-up visits following a loading phase of 3 monthly injections. MAIN OUTCOME MEASURES: Incidence of blindness and sight impairment (VA in the better-seeing eye <38 letters [≤20/200 Snellen, approximately], and <68 letters [≤20/50 Snellen, approximately] at 2 consecutive visits, or 1 visit if no further follow-up data) in each year after initiating treatment. RESULTS: Information from >300 000 clinic visits (2.8 million data points) collected over 5 years was collated from 14 centers. Mean age at first treatment was 79.7 years (standard deviation = 9.19 years), with a female preponderance (63%). The mean (median) VA at baseline in the better-seeing eye was 67.2 (72.0) letters, 20/40- (20/40+) approximate Snellen conversion. The cumulative incidence of new blindness and sight impairment in patients with treated nAMD in at least 1 eye at years 1 to 4 after first injection were 5.1%, 8.6%, 12% and 15.6% for new blindness and 29.6%, 41.0%, 48.7%, and 53.7% for new sight impairment, but with significant reductions in the rates between year cohorts initiating treatment (blindness [P = 4.72 × 10-08], sight impaired [P = 3.27 × 10-06]). CONCLUSIONS: To the best of our knowledge, this is the first multicenter real-world study on the incidence of blindness and sight impairment based on VA data in patients treated with ranibizumab for nAMD, and its results show low incidences of both blindness and sight impairment, which both declined during the study period.
PURPOSE: To study the incidence of blindness and sight impairment in treatment-naive patients receiving ranibizumab (Lucentis) for neovascular age-related macular degeneration (nAMD) in the United Kingdom (UK) National Health Service. DESIGN: Multicenter nAMD database study. PARTICIPANTS: A total of 11 135 patients who collectively received 92 976 treatment episodes to 12 951 eyes. METHODS: Data were extracted from 14 UK centers using the same electronic medical record system (EMR). The EMR-mandated collection of a data set (defined before first data entry) including: age, Early Treatment Diabetic Retinopathy Study visual acuity letter score (VA) for both eyes at all visits, and injection episodes. Participating centers used overwhelmingly a pro re nata re-treatment posology at intended monthly follow-up visits following a loading phase of 3 monthly injections. MAIN OUTCOME MEASURES: Incidence of blindness and sight impairment (VA in the better-seeing eye <38 letters [≤20/200 Snellen, approximately], and <68 letters [≤20/50 Snellen, approximately] at 2 consecutive visits, or 1 visit if no further follow-up data) in each year after initiating treatment. RESULTS: Information from >300 000 clinic visits (2.8 million data points) collected over 5 years was collated from 14 centers. Mean age at first treatment was 79.7 years (standard deviation = 9.19 years), with a female preponderance (63%). The mean (median) VA at baseline in the better-seeing eye was 67.2 (72.0) letters, 20/40- (20/40+) approximate Snellen conversion. The cumulative incidence of new blindness and sight impairment in patients with treated nAMD in at least 1 eye at years 1 to 4 after first injection were 5.1%, 8.6%, 12% and 15.6% for new blindness and 29.6%, 41.0%, 48.7%, and 53.7% for new sight impairment, but with significant reductions in the rates between year cohorts initiating treatment (blindness [P = 4.72 × 10-08], sight impaired [P = 3.27 × 10-06]). CONCLUSIONS: To the best of our knowledge, this is the first multicenter real-world study on the incidence of blindness and sight impairment based on VA data in patients treated with ranibizumab for nAMD, and its results show low incidences of both blindness and sight impairment, which both declined during the study period.
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